Randomised trial of cord clamping and initial stabilisation at very preterm birth.

OBJECTIVES

For very preterm births, to compare alternative policies for umbilical cord clamping and immediate neonatal care.

DESIGN

Parallel group randomised (1:1) trial, using sealed opaque numbered envelopes.

SETTING

Eight UK tertiary maternity units.

PARTICIPANTS

261 women expected to have a live birth before 32 weeks, and their 276 babies.

INTERVENTIONS

Cord clamping after at least 2 min and immediate neonatal care with cord intact, or clamping within 20 s and immediate neonatal care after clamping.

MAIN OUTCOME MEASURES

Intraventricular haemorrhage (IVH), death before discharge.

RESULTS

132 women (137 babies) were allocated clamping ≥2 min and neonatal care cord intact, and 129 (139) clamping ≤20 s and neonatal care after clamping; six mother-infant dyads were excluded (2, 4) as birth was after 35 weeks, one withdrew (death data only available) (0, 1). Median gestation was 28.9 weeks for those allocated clamping ≥2 min, and 29.2 for those allocated clamping ≤20 s. Median time to clamping was 120 and 11 s, respectively. 7 of 135 infants (5.2%) allocated clamping ≥2 min died and 15 of 135 (11.1%) allocated clamping ≤20 s; risk difference (RD) -5.9% (95% CI -12.4% to 0.6%). Of live births, 43 of 134 (32%) had IVH vs 47 of 132 (36%), respectively; RD -3.5% (-14.9% to 7.8%). There were no clear differences in other outcomes for infants or mothers.

CONCLUSIONS

This is promising evidence that clamping after at least 2 min and immediate neonatal care with cord intact at very preterm birth may improve outcome; a large trial is urgently needed.

TRIAL REGISTRATION

ISRCTN 21456601.